MAUDE Adverse Event Report: ACCUTRON, INC. ULTRA PC% CABINET MOUNT FLOWMETER

Model Number 27514

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Convulsion/Seizure (4406)

Event Date 07/14/2022

Event Type  malfunction  

Event Description

The user facility reported that during a patient procedure involving the ultra pc% flowmeter the patient went blue and started seizing.The patient was sent to the emergency room and was reported to have fully recovered.

Manufacturer Narrative

Accutron has contacted the user facility requesting the device subject of the event be returned to accutron for evaluation.The investigation into the reported event is in process; a follow-up mdr will be submitted when additional information becomes available.

Manufacturer Narrative

The user facility indicated the reported event occurred on july 14, 2022 and accutron was first made aware of this issue on october 7, 2022.The user facility has continued to use the unit subject of the event since july 2022 and no additional issues have been reported.Through follow-up with the user facility, accutron learned that immediately following the reported event user facility personnel had administered 100% oxygen for 10 minutes and the patient recovered.As a precaution, the patient was sent to the emergency room for evaluation.Accutron requested and received the unit subject of the event for evaluation.The unit was tested and found to be operating according to specifications.The ultra pc% cabinet mount flowmeter instructions for use states, "to be used only by a professional trained in the use of nitrous oxide.Patient should always be closely monitored during nitrous oxide use.If patient has an adverse reaction, reduce or stop the flow of nitrous oxide as needed.The o2 flush button can be used to rapidly purge the lines of n2o.".Accutron counseled user facility personnel on the proper use and operation of the flowmeter.No additional issues have been reported.

• Brand Name: ULTRA PC% CABINET MOUNT FLOWMETER
• Type of Device: FLOWMETER
• Manufacturer (Section D): ACCUTRON, INC.; 1733 west parkside ln.; phoenix AZ 85027
• Manufacturer (Section G): ACCUTRON, INC.; 1733 west parkside ln.; phoenix AZ 85027
• Manufacturer Contact: daniel davy ; 5960 heisley rd.; mentor, OH 44060 ; 4403927453
• MDR Report Key: 15735581
• MDR Text Key: 307185703
• Report Number: 2020813-2022-00006
• Device Sequence Number: 1
• Product Code: BSZ
• UDI-Device Identifier: 00813830023701
• UDI-Public: 00813830023701
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date: 11/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 27514
• Device Catalogue Number: 27514
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/07/2022
• Initial Date FDA Received: 11/04/2022
• Supplement Dates Manufacturer Received: 10/07/2022
• Supplement Dates FDA Received: 01/12/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1